Prolonged Exposure and Oxytocin

Phase 2

Completed

• Conditions: PTSD
• Interventions: Drug: Oxytocin; Drug: Placebos

• Registration Number: NCT03238924
• Lead Sponsor: Medical University of South Carolina

Brief Summary

Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong biological and theoretical rationale for investigating the potential effectiveness of augmenting PE with intranasal oxytocin, no studies to date have done so. The current study aims to address this important gap in the literature by examining changes in PTSD symptoms following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-03
• Results First Submitted: 2018-01-29
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-26
• Last Update Submitted: 2018-04-26
• Results First Posted: 2018-05-25
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Male or female; any race or ethnicity; age 18-75 years.
2. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
3. Participants must be able to comprehend English.
4. Meet DSM-5 criteria for current PTSD (assessed via the Clinician Administered PTSD Scale; CAPS).
5. A CAPS score of 50 or greater.
6. Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders (e.g., agoraphobia, social phobia, generalized anxiety disorder). The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD.
7. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least eight weeks before study initiation. Initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.

Exclusion Criteria

1. Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those participants will be referred clinically.
2. Participants who would present a serious suicide risk or who are likely to require hospitalization during the course of the study. Those participants will be referred clinically.
3. Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 8 weeks.
4. Participants meeting DSM-5 criteria for a substance use disorder, except caffeine or nicotine, within the past 12 months.
5. Pregnant women will be excluded from the proposed study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin	Oxytocin	40 IU intranasal oxytocin spray
Placebo	Placebos	Placebo is matching saline nasal spray

Primary Outcome Measures

Name	Time	Method
PTSD Symptom Severity	Change from Baseline to end of treatment (10 weeks)	Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 scores range from 0-120. Items are summed to obtain a total score with higher scores reflective of greater symptom severity.

Secondary Outcome Measures

Name	Time	Method
PTSD Symptom Severity	Change from Baseline to end of treatment (10 weeks)	PTSD Checklist (PCL). The PCL is a self-report measure which uses a 5-point scale to assess the frequency and severity of PTSD symptoms. Item responses are summed to obtain a total score ranging from 17-85 with greater scores reflective of greater symptom severity.
Depression Symptom Severity	Change from Baseline to end of treatment (10 weeks)	Beck Depression Inventory-II. The BDI-II is a self-report measure where each item is rated on a 0-3 scale and summed to obtain a total score. Greater scores are reflective of greater symptom severity.